Individualized vs Standard Ventilation for Surgery

Overseen By William G Tharp, MD PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Vermont Medical Center

Disqualifiers: Current smoker, Lung disease, Cardiac impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether different ventilator settings during surgery affect heart and lung function. One group will receive standard ventilator settings, while the other will have settings adjusted based on specific internal pressure measurements (transpulmonary pressure-guided ventilation). The study seeks participants undergoing robotic laparoscopic surgery who have no serious lung or heart conditions and are non-smokers. Researchers will monitor participants during and after surgery to assess how these settings impact recovery. As an unphased trial, this study allows participants to contribute to important research that could enhance surgical outcomes for future patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that these ventilator settings are safe for surgery?

Research shows that using lung pressure to guide breathing support during surgery is generally safe for patients. Studies have found that this method can protect the lungs by reducing stress. Patients have responded well to these settings, with fewer lung-related issues reported after surgery.

In some studies, patients experienced fewer problems, such as excessive air trapped in their lungs. This suggests that this technique might be safer than other methods. Overall, the safety information appears promising, but discussing any concerns with a doctor before joining a trial is always important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial comparing ventilation strategies because it aims to personalize how ventilators are set up during surgery. While standard practices use general settings based on a patient's condition and the surgery type, this trial explores adjusting settings based on individual transpulmonary pressures, a method not routinely used. By tailoring ventilation to each patient’s specific lung pressures, the approach could potentially reduce lung stress and improve outcomes. This level of customization in ventilation could mark a significant shift in surgical care, making it more precise and potentially safer.

What evidence suggests that this trial's ventilator settings could be effective for surgery?

This trial compares individualized lung protective ventilator settings with standard settings during surgery. Research has shown that personalized ventilator settings, like those tested in the individualized arm of this trial, can improve breathing and lung function. Studies have found that adjusting the ventilator based on lung pressure enhances oxygen levels and lung performance. This approach also reduces the risk of lung problems after surgery. Specifically, for heart surgery patients, these customized settings have led to better breathing outcomes. Overall, tailoring ventilator settings to individual needs greatly benefits lung health during surgery. ^{1 2 4 6 7}

Who Is on the Research Team?

William G Tharp, MD PhD

Principal Investigator

University of Vermont Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are having robotic-assisted laparoscopic surgery in a specific position at the University of Vermont Medical Center. They must be able to give consent and speak English. Smokers, those with significant past smoking history, lung diseases like asthma or COPD, heart problems, esophageal issues, or other conditions that could affect participation are excluded.

Inclusion Criteria

I am having robotic surgery in a specific position at the University of Vermont Medical Center.

Signed consent form

Exclusion Criteria

Any other co-morbid condition that, in the opinion of the study investigators, may interfere with study participation

Current smoker

Smoking history ≥20 pack years

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Preoperative Assessment

Measurement of the patient's waist size and weight, and administration of an 8-item verbal questionnaire about respiratory symptoms

1 day

1 visit (in-person)

Intraoperative Procedure

Patients undergo surgery with either standard or individualized lung protective ventilator settings, with ultrasound exams and pressure measurements

Duration of surgery

Postoperative Follow-up

Patients are telephoned 30 days after surgery to ask about their recovery and repeat the 8-item respiratory symptom questionnaire

30 days post-surgery

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Balloon Catheter Placement
• Telephonic Follow-up
• Transpulmonary Pressure Guided Ventilation
• Ultrasound Probe Insertion

Trial Overview The study tests if different ventilator settings during surgery can influence how pressures in the lungs affect heart function. Patients will either receive standard ventilation or individualized adjustments based on pressure measurements taken every 30 minutes with a balloon catheter. Heart and lung function will be monitored using ultrasound before and after surgery.

How Is the Trial Designed?

Group I: Individualized lung protective ventilator settings Experimental Treatment 1 Intervention

Lung-protective ventilator settings will be individualized based on the patient's transpulmonary pressures (TPP), as measured by esophageal manometry.

Group II: Standard lung protective ventilator settings Active Control 1 Intervention

Ventilator settings will be adjusted to standard lung-protective settings according to the anesthesiologist's clinical judgement for the patient, their comorbodities, and the surgical procedure.

Who Is Running the Clinical Trial?

University of Vermont Medical Center

Lead Sponsor

Trials

46

Recruited

25,900+

Published Research Related to This Trial

Mechanical ventilation can either worsen lung injury in patients with or at risk for ARDS or help reduce mortality if properly adjusted, highlighting the importance of personalized ventilation strategies.

Current practices often use a standard approach for setting tidal volume and PEEP, but evidence suggests that optimizing PEEP based on individual lung pathology rather than solely on oxygenation could improve patient outcomes, though no consensus exists on the best method for personalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalizing mechanical ventilation according to physiologic parameters to stabilize alveoli and minimize ventilator induced lung injury (VILI). Nieman, GF., Satalin, J., Andrews, P., et al.[2020]

A multicenter trial involving 420 patients with moderate-to-severe ARDS found that personalizing mechanical ventilation based on lung morphology did not significantly reduce 90-day mortality compared to standard care (hazard ratio 1.01).

Misclassification of patients' lung morphology was common (21%), and those misclassified had higher mortality rates when treated with personalized ventilation, suggesting that accurate phenotyping of ARDS is crucial for effective treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalised mechanical ventilation tailored to lung morphology versus low positive end-expiratory pressure for patients with acute respiratory distress syndrome in France (the LIVE study): a multicentre, single-blind, randomised controlled trial. Constantin, JM., Jabaudon, M., Lefrant, JY., et al.[2020]

A personalized mechanical ventilation strategy for patients with ARDS, which considers lung physiology, imaging, and biological phenotypes, may enhance treatment outcomes, but more research is needed before implementation in clinical settings.

Monitoring specific ventilatory parameters, such as low tidal volume and driving pressures, along with techniques like esophageal pressure monitoring, can help tailor ventilation settings to individual patient needs, potentially improving safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized mechanical ventilation in acute respiratory distress syndrome. Pelosi, P., Ball, L., Barbas, CSV., et al.[2021]

In a study of 30 patients undergoing thoracic surgery, individualized positive end-expiratory pressure (PEEP) significantly improved oxygenation and lung mechanics during one-lung ventilation compared to a standardized PEEP of 5 cm·H2O.

The study group maintained higher arterial oxygenation levels (306 mm·Hg) and showed significant improvements in static compliance after adjusting PEEP, while the control group experienced decreased oxygenation, highlighting the efficacy of individualized PEEP in enhancing respiratory function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Setting individualized positive end-expiratory pressure level with a positive end-expiratory pressure decrement trial after a recruitment maneuver improves oxygenation and lung mechanics during one-lung ventilation. Ferrando, C., Mugarra, A., Gutierrez, A., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12337742/

Effect of driving pressure-guided positive end-expiratory ... The primary outcomes were the effects on the driving pressure (DP), static respiratory compliance and plateau pressure (Pplat). Secondary ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0007091224003118

Association between driving pressure-guided ventilation ... This meta-analysis indicates that driving pressure-guided ventilation is associated with a lower risk of PPCs in non-cardiothoracic surgery but not in ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6639048/

Driving Pressure and Transpulmonary Pressure: How do ... Application of such transpulmonary pressure based approaches lead to improved oxygenation, respiratory system compliance and a trend to reduction in mortality ...

4. nature.com nature.com/articles/s41598-025-85283-w

Lung protective ventilation guided by driving pressure ... Lung protective ventilation guided by driving pressure improves pulmonary outcomes in heart transplantation | Scientific Reports.

5. bjanaesthesia.org bjanaesthesia.org/article/S0007-0912(22)00367-1/fulltext

Driving pressure-guided ventilation and postoperative ... Conclusions. In lung resection surgery, a driving pressure-guided ventilation improved pulmonary mechanics intraoperatively, but did not reduce ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0007091222003671

Driving pressure-guided ventilation and postoperative ... We also obtained data on intervention-related adverse events (safety outcomes) including dynamic hyperinflation during recruitment, recruitment interruption ...

7. ccforum.biomedcentral.com ccforum.biomedcentral.com/articles/10.1186/s13054-024-04950-y

Transpulmonary pressure monitoring in critically ill patients This technique allows partitioning of the respiratory mechanics between the lungs and the chest wall, provides information on lung recruitment and risk of ...